Ultrasound-assisted Spinal Anesthesia in Midline Versus Paramedian Approach in Adult Orthopedic Surgery

NCT ID: NCT07047469

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-13

Study Completion Date

2025-12-20

Brief Summary

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This study aims to compare between the two methods (midline and paramedian approach of spinal anesthesia guided by ultrasound) by the number of needle passes required to successful dural puncture.

Detailed Description

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Conditions

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Anesthesia; Functional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group (1): spinal anesthesia with median approach

patients undergoing orthopedic surgery will receive spinal anesthesia with median approach under ultrasound guided techniques

Group Type ACTIVE_COMPARATOR

Group (1): spinal anesthesia with median approach

Intervention Type PROCEDURE

patients undergoing orthopedic surgery will receive spinal anesthesia with median approach under ultrasound guided techniques

Group (2): spinal anesthesia with paramedian approach

patients undergoing orthopedic surgery will receive spinal anesthesia with paramedian approach under ultrasound guided techniques

Group Type ACTIVE_COMPARATOR

Group (2): spinal anesthesia with paramedian approach

Intervention Type PROCEDURE

patients undergoing orthopedic surgery will receive spinal anesthesia with paramedian approach under ultrasound guided techniques

Interventions

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Group (1): spinal anesthesia with median approach

patients undergoing orthopedic surgery will receive spinal anesthesia with median approach under ultrasound guided techniques

Intervention Type PROCEDURE

Group (2): spinal anesthesia with paramedian approach

patients undergoing orthopedic surgery will receive spinal anesthesia with paramedian approach under ultrasound guided techniques

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients will perform orthopedic surgery
* Physical state I or II according to ASA classification
* Age between (18 - 50 )
* Body mass index less than 30

Exclusion Criteria

* Patient refusal .
* Local infection at the puncture site .
* Allergy to any of the drugs to be administrated .
* Old age patients
* Obese patients
* Previous spinal surgery .
* Spinal stenosis .
* Multiple sclerosis .
* Coagulopathy.
* Hypovolemia .
* Systemic infection .
* Aortic stenosis .
* Spina bifida and back deformity .
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Areej Mohamed Abdelkader

Resident, Department of Anesthesia, Intensive Care and Pain management, Faculty of Medicine, Sohag University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Areej M Abd Elkader, Resident

Role: CONTACT

01288811379

Ahmed E Abd Elrahman, Professor

Role: CONTACT

01118011611

Facility Contacts

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Magdy M Amin, Professor

Role: primary

01090801900

References

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Zeng W, Shi Y, Zheng Q, Du S. Ultrasound-assisted modified paramedian technique for spinal anesthesia in elderly. BMC Anesthesiol. 2022 Jul 30;22(1):242. doi: 10.1186/s12871-022-01751-0.

Reference Type BACKGROUND
PMID: 35907825 (View on PubMed)

Singh B, Sohal AS, Singh I, Goyal S, Kaur P, Attri JP. Incidence of Postspinal Headache and Low Backache Following the Median and Paramedian Approaches in Spinal Anesthesia. Anesth Essays Res. 2018 Jan-Mar;12(1):186-189. doi: 10.4103/aer.AER_139_17.

Reference Type BACKGROUND
PMID: 29628579 (View on PubMed)

Wilson JM, Farley KX, Erens GA, Guild GN 3rd. General vs Spinal Anesthesia for Revision Total Knee Arthroplasty: Do Complication Rates Differ? J Arthroplasty. 2019 Jul;34(7):1417-1422. doi: 10.1016/j.arth.2019.03.048. Epub 2019 Mar 28.

Reference Type BACKGROUND
PMID: 31005435 (View on PubMed)

Other Identifiers

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Soh-Med--25-6-16MS

Identifier Type: -

Identifier Source: org_study_id

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